Leads the site's Validation organization, which is responsible to oversee and drive the site risk management program to ensure capability and control of all manufacturing processes, and to provide oversight of product and process transfers, changes, and additions to ensure they are conducted with technical and scientific rigor, including demonstrations of process capability and clearly defined process control plans.
Accountable to ensure the development, execution and maintenance of the SVMP (Site Validation Master Plan) activities, including periodic review and process/equipment revalidation Oversee site risk management program to ensure process capability and control for the all products manufactured at the site, and end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle. Support excellence in manufacturing by assuring that a comprehensive validation and process control program is implemented and maintained. Support cross-functional root cause analysis and problem solving on escalated technical product / process issues (e.g., recurring deviations, quality-investigations, CAPA-studies). Ensure development and deployment of highly specialized skills appropriate to the Validation team to meet the needs of the site's product portfolio and strategy. Foster knowledge development and transfer among the Validation team. Design and support delivery of technical training (e.g., define training curriculum technical content), and to maximize opportunities to leverage shared training for validation and product stewards on Site/Region/Business Unit base. Works with the other Site Validation teams and networks, of the relevant Region or Business Unit, driving reapplication of standard work processes, reapplication of best practices specifically in validation, training, process changes and handling of discrepancy and investigation resolution. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements BSc. in Chemistry, Pharmacy, Chemical Engineering or Pharmaceutical Technology. Desirable PhD in the above or equivalent. Fluent in English and in local site language. 8 years experience in manufacturing/ manufacturing science and technology/technical development/Quality. Thorough understanding of manufacturing processes and related process equipment. Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. 5 years experience in executing process validation, having led and managed validation projects. Expert in reviewing and writing technical reports. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions
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Director, Regional Sales
Kristen oversees the entire 50-person Regional Sales Team for Alcon’s cataracts business in America. She helps handle products and services associated with the surgical side of operations.
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